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CompletedNCT01557231Updated Mar 29, 2018

Epidemiology of Osteoarthritis (OA) Pain

An observational study in Osteoarthritis, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2018-03-29.

Sponsored by Northwestern University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
86
Ages
40 Years and older
Sex
All
01

Study summary

Chronic pain, by definition, persists over long periods of time, but both sufferers of pain and their caregivers are aware that pain levels can fluctuate greatly over time. Being able to define pain variability and its underlying causes would be an important advance in our understanding of chronic pain, and would in turn lead to better approaches to the treatment of chronic pain. In this study, the investigators propose to evaluate in 60 people with chronic pain of the knee due to osteoarthritis over 3 months, collecting data regarding magnitude of pain, physical activity level, and medication status twice daily during this period of time. The investigators then will assess the variability in pain levels over time, the frequency of "flares" of osteoarthritis (OA) pain and their relationship to physical activity, medications, and clinical descriptors of the population, e.g., age, gender, body mass index (BMI). Additionally, evaluations will be made regarding temporal patterns of OA knee pain as well as assessment of subgroups of patients with the overall group being studied.

02

Conditions studied

  • Osteoarthritis

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Keywords

  • OA
  • osteoarthritis
  • pain
  • variability
  • activity
  • treatment
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.

This study's enrollment of 86 is below the median of 100 across 792 observational studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Individuals with OA

Inclusion criteria

  1. Men and women, age 40 years and above
  2. Knee pain most days of the week for the past month
  3. Diagnosis of knee OA
  4. Meet ACR criteria for knee OA
  5. No significant limitations in physical activity
  6. Own and able to use a cellular phone capable of text messaging
  7. Able to return for all clinic visits
  8. Able to read and understand the informed consent document

Exclusion criteria

Exclusion Criteria:

  1. Use of a walker to ambulate or inability to ambulate (use of cane is allowed)
  2. Other forms of arthritis
  3. Other major causes of pain that could be expected to interfere with assessment of pain during this trial, e.g., recurrent migraine, back pain, fibromyalgia
  4. Scheduled for and likely to need joint replacement surgery in the next 3 months
  5. Any medical condition that in the judgment of the investigator would make the participant not suitable for the study
  6. Living in a long-term care facility
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
86 participants (actual)

Groups and cohorts

  • No treatment

    OA

06

What researchers measure

Primary outcomes

  1. pain magnitude

    magnitude of pain will be evaluated 3x/day

    Time frame: 6 months

Secondary outcomes

  1. self-reported activity level

    data will be collected 3x/day; Likert 1-5 scale

    Time frame: 6 months

07

Study locations

1 site
  • Northwestern University Feinberg School of Medicine
    Chicago, Illinois 60611, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01557231
Lead sponsor
Northwestern University
Collaborators
ZARS Pharma Inc.
Responsible party
Thomas J. Schnitzer (Professor, Northwestern University) — Principal investigator
First posted
Mar 19, 2012
Start date
Mar 2012
Primary completion
Sep 2015
Completion
Sep 2015
Last update
Mar 29, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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